Cosmetic Labeling Requirements: What EU Brands Must Change

A serum brand in Lyon ships its first pallet to the US. Every bottle is fully compliant in Paris: “30 ml,” “Aqua” at the top of the ingredient list, “CI 77891” for the white pigment, a jar symbol showing 12 months after opening and the text in French and English. In the US, three of those details need changing before a single bottle can sell, and the bilingual text creates a fourth problem most brands never see coming.

Label claims are where imported cosmetics most often go wrong. FDA refused 1,300 batches of imported cosmetics in 2024, and 723 of them, more than half, were refused because their claims turned a cosmetic into an unapproved drug (ChemLinked, 2025). This checklist shows exactly what to change on an EU label for the US market, what you can keep and how to fit relabeling into your plans for cosmetics fulfillment services in the US.

Key Takeaways for Cosmetic Labeling Requirements

• US cosmetic labels have two zones: the front panel carries the product identity and net quantity, and the information panel carries everything else.
• Net quantity must be stated in US units such as fl oz. Keep the metric figure next to it, because federal packaging law asks for both.
• FDA does not accept “Aqua,” “Parfum” or CI numbers on their own. Write “Water (Aqua),” “Fragrance (Parfum)” and the FDA color name with the CI number in brackets.
• If your label adds a second language, every required statement must appear in that language too, so a half-translated EU label can be misbranded.
• PAO symbols, expiry dates and batch codes are not required in the US, but keeping them costs nothing and helps you handle complaints.

What Are Cosmetic Labeling Requirements?

In the US, cosmetic labeling requirements are the rules for what must appear on a cosmetic’s packaging, where it must appear and how large it must be. They come from three laws: the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act and, since 2022, MoCRA. FDA sets the detail in 21 CFR Part 701 and Part 740. There is no label approval step: you design the label, FDA can check it at the border or in the market, and a product with a non-compliant label is treated as misbranded (US Food and Drug Administration, 2025).

The Two Panels on a US Cosmetic Label

US rules split the outer package into a principal display panel, the side a shopper sees first, and an information panel, usually the back or side. Each required element has a home.

Type size

Ingredient letters must be at least 1/16 inch tall, or 1/32 inch when the whole package has less than 12 square inches available for labeling. The net quantity has its own scale based on the size of the front panel: 1/16 inch for panels of 5 square inches or less, 1/8 inch up to 25 square inches and 3/16 inch up to 100 square inches (Electronic Code of Federal Regulations, 2026). Small EU tubes printed at the EU minimum often fall short here.

EU vs US Cosmetic Labels, Side by Side

Both systems want the same basics, but they ask for them in different words, units and places. This is the comparison an EU label designer needs.

Sources: Regulation (EC) No 1223/2009, Article 19; 21 CFR Part 701; 21 U.S.C. 364e; 19 U.S.C. 1304.

The EU to US Label Change Checklist

Work through these with your packaging designer before you print a US run or order over-stickers.

Net quantity in US units

FDA’s regulation requires weight in ounces or volume in fluid ounces, placed in the bottom 30% of the front panel, and treats the metric figure as optional (Electronic Code of Federal Regulations, 2026). The Fair Packaging and Labeling Act, however, calls for both customary and metric units (15 U.S.C. 1453, 1992). Showing both, such as “1 fl oz (30 mL),” satisfies both and keeps your EU figure.

Ingredient names FDA accepts

FDA asks for each ingredient’s common or usual name in English and does not accept EU alternatives as substitutes. It does not object to the EU term in brackets after the English name (US Food and Drug Administration, 2022).

The order rules are close to the EU’s: ingredients above 1% go in descending order, ingredients at 1% or less may follow in any order, and color additives may be grouped at the end.

Name, place of business and a US-reachable contact

The information panel must name the manufacturer, packer or distributor and its place of business. If the named company did not make the product, the name must be qualified with wording such as “Manufactured for” or “Distributed by” (Electronic Code of Federal Regulations, 2026). Since December 29, 2024, the label must also carry a domestic address, domestic phone number or electronic contact information for adverse event reports (21 U.S.C. 364e, 2022). Our guide to MoCRA requirements explains who that contact must reach and what happens next.

Country of origin in English

Every imported article must show its country of origin in English, in a conspicuous place and as permanently as the product allows, so the final US buyer can see where it was made. “Made in France” works; “Fabriqué en France” alone does not. Goods that arrive unmarked and are not marked under customs supervision face an extra 10% duty that cannot be waived (19 U.S.C. 1304, 1930).

English first, and the second-language trap

All required statements must be in English. The rule most EU brands miss is the next one: if a label contains any representation in a foreign language, every statement required on the label must also appear in that language (Electronic Code of Federal Regulations, 2026). A French product name with only an English ingredient list is a problem. Either translate everything required or keep the US label in English only.

Warnings where your product needs them

Some products need set warnings, including aerosol sprays, feminine deodorant sprays and children’s bubble bath. A product whose safety has not been adequately substantiated must carry “Warning: The safety of this product has not been determined” (US Food and Drug Administration, 2025). EU precautions do not translate automatically into these US statements, so check each one against 21 CFR Part 740.

What You Can Keep From Your EU Label

Not everything on an EU label is wasted in the US. Several EU elements have no US requirement but no US objection either.

Keeping the batch code is worth it even though FDA does not require it. When a customer reports a reaction, the batch number is how you trace which production run, and which stock in the warehouse, is affected.

When Your Cosmetic Label Becomes a Drug Label

In the EU, a sunscreen is a cosmetic. In the US, any product claiming sun protection, acne treatment, dandruff control or sweat prevention is a drug, or both a cosmetic and a drug. That changes the label completely: active ingredients come first, and the product needs a standard “Drug Facts” panel in the format set by 21 CFR 201.66 (Electronic Code of Federal Regulations, 2026). Drug claims were behind more than half of the 2024 import refusals, which is why the claims review in our guide to MoCRA matters as much as the label itself.

If a product is not ready to follow US drug rules, the practical route is to remove the drug claim from the US version and launch it as a cosmetic, then add the drug version later.

Labeling Rules Still Changing in 2026

The EU change helps you. If your US labels already list allergens individually, as the EU now requires above 0.001% in leave-on products and 0.01% in rinse-off products, you will already disclose more than current US rules require (European Union, 2023). California’s Proposition 65 is separate: it requires a warning when a product exposes Californians to a listed chemical above set levels (California Office of Environmental Health Hazard Assessment, 2026), so check your formula against the list before you ship there.

Where Relabeling Fits Into Your US Launch

You have three ways to get compliant labels onto US stock, and the right one depends on volume.

• A US print run: best once volumes justify a separate packaging order. Cleanest result, longest lead time.
• Over-stickers applied at origin: good for a first shipment. The goods leave the factory already marked, which also covers the country-of-origin rule at the border.
• Labels applied in the US: useful for small corrections after arrival. FDA’s guidance confirms that a site that only labels or relabels finished products is not a facility that must register under MoCRA (US Food and Drug Administration, 2024).

One timing point matters. Country-of-origin marking is checked at entry, so a missing “Made in” mark should be fixed before the goods ship, not after they reach a warehouse.

How DSCP Smart Fulfillment Helps Beauty Brands Launch in the US

Label decisions are yours, and a regulatory consultant can confirm the wording. Once compliant stock arrives, DSCP Smart Fulfillment handles the rest of your beauty product fulfillment:

• Labels and inserts applied to one standard: our kitting and assembly service applies the barcode labels, sleeves and inserts you supply to one written packing standard.
• Fast receiving: every inbound delivery is counted against your purchase order and live within 24 to 48 hours.
• Two coasts: European stock lands through the Port of New York and New Jersey at our east coast 3PL warehouse, and Australian or Asian stock reaches our west coast fulfillment center through Los Angeles or Long Beach.
• US delivery: 2 to 4 day ground delivery to about 80% of the US population, with same-day dispatch on orders released by 5 PM EST.
• Import support: customs brokerage and regulatory advice come through our partner network, and we tell you which is which before you commit.

Get Your US Launch Plan in Writing

Send us your product list, current labels and expected US order volume. We will map the route, the warehouse and an itemized cost per order, so you can plan your US label run around real numbers. Request your free landed-cost review.

Conclusion

An EU label is a strong starting point for the US. The changes are specific: US units next to metric, English ingredient names with the EU terms in brackets, a named distributor and a US-reachable contact, “Made in” in English and no drug claims unless the product follows drug rules. Watch the second-language rule, keep your batch codes and PAO symbols, and check the new allergen and California rules before each print run.

With the label settled, the rest of the US launch is about getting stock in and orders out quickly, which is what our skincare fulfillment service is built for.